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Noise ExposureNCT04777695

Sound Levels in the Pediatric Cardiac Critical Care Unit and Their Correlation With Sedation Administration, Delirium Scores and Patient Heart Rate

An observational study of Noise Exposure and Sedative Withdrawal Delirium, run by Children's National Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is limited data regarding sound levels and burden in the pediatric cardiac critical care unit and how this compares with WHO standards. We seek to record this data and correlate sound level with bolus sedation administration, patient delirium scores, and patient heart rate trends. Read more about this study

Who is it for?
Ages Up to 22 years
What is being tested?
Decibel Monitor
How many people
64 participants
Where
1 siteUnited States
Study dates
1 Mar 2021to 1 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 22 years
  • All sexes
  • Child, Adult

Study population: Cardiac Critical Care patients include patients admitted for evaluation of congenital heart disease, status post repair of that disease, arrhythmia or for other management of pediatric patients with these conditions.

Who may be able to join

  • All children admitted to the pediatric CICU during a one month period of time for patients aged 0 to less than or equal to 22 years of age, as per the World Health Organization definition of a pediatric patient.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's National Hospital

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

There is limited data regarding sound levels and burden in the pediatric cardiac critical care unit and how this compares with WHO standards. We seek to record this data and correlate sound level with bolus sedation administration, patient delirium scores, and patient heart rate trends.

Primary Outcomes

  • 1 peak sound level in cardiac ICU in decibels
  • 2 Mean sound level in cardiac ICU in decibels
  • 3 Compare sound levels to WHO recommendations

Secondary Outcomes

  • 1 To explore patient and unit factors that might influence these levels
  • 2 To analyze sound levels in post-operative neonates, versus infants, versus children
  • 3 To analyze patients on invasive versus non-invasine versus no ventilation
Read the detailed description

This study aims to measure and average sound levels during hospitalization in the Children's National Pediatric Cardiac Intensive Care Unit (CICU) and investigate any correlation between heightened sound levels, the incidence of delirium, the administration of sedation medications given for agitation, and patient heart rate changes. Recognition of modifiable risk factors, such as sound levels, can lead to the development of preventive strategies to keep sound levels within recommended guidelines and to lessen the amount of sedation medications that are given for agitation. Successful completion of this research will contribute to the development of modifiable environmental factors for the prevention of oversedation and delirium in critically ill children, potentially improving outcomes in a vulnerable patient population. This will be the first study of this nature performed in a large CICU and the first to look at delirium scores and vital sign changes as related to sound levels.

Many studies have shown that increased sound levels in hospitals can worsen patient agitation and lead to sleep disturbance and impair rest and healing. The World Health Organization and the Environmental Protection Agency mandate that hospital sound levels not exceed 40-45 decibels dB(A) during the day and 35 dB(A) at night. Previous studies in four European ICUs with adult patients showed that ICUs demonstrated higher than recommended sound levels 50% of the time, with an average sound level of 51 dB(A) over 24 hours and a peak sound level of 85 dB(A). In the only published study on sound levels in a pediatric CICU and their relationship to sedation administration, Guerra et al showed in 2017 that mean levels were over 59dB in both open patient areas as well as single rooms with little variation between day and night levels and that a higher peak and average sound level correlated with more sedation boluses in the subsequent 2 and 5 hours respectively.

The association between neurotoxicity and the use of sedatives and analgesia in young infants with congenital heart disease has also been described. In addition, there are appreciable negative hemodynamic effects of oversedation on the pediatric patient recovering from cardiac surgery. For this reason, it is important to investigate the impact that sound levels might have on sedation administration. Along with this, as vital sign changes such as an elevated heart rate can lead to patients receiving additional sedation, it is equally important to study the relationship between patient heart rate and sound level in a cardiac intensive care unit.

Delirium is defined as an acute and fluctuating change in attention, thinking, perception, and consciousness secondary to an underlying medical condition. The consequences of delirium have been well studied in the adult critical care population, and include prolonged hospitalization time, difficulty with long-term thinking, increased days of mechanical ventilation, and increased risk of death after discharge from the hospital. In adult intensive care units, delirium screening is routinely performed because of the known consequences of the disease. With the advent of the Cornell Assessment of Pediatric Delirium (CAPD), there is now a rapid and reliable method of screening for delirium in pediatric intensive care units. Since 2018, bedside nurses in the Children's National CICU have been trained to calculate CAP-D scores. This delirium assessment performed once per shift, can be analyzed side-by-side with average sound levels over that same shift to assess for any correlation between these two parameters.

Being tested
Decibel Monitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Decibel MonitorOther

    Placement of a TeckPro data logging sound decibel meter at all patient bed-spaces to measure concurrent sound levels 24 hours per day, over a one (1) month period. Peak and mean sound levels per hour will be collected by the decibel monitor. Sound collected every 5 minutes will be logged by the decibel monitor and downloaded onto manufacturer software daily; data will then be imported into Microsoft Excel for further data analysis.

Study groups in NCT04777695
Study groupRoleWhat they receive
CICU InpatientsThis is a prospective observational study of all children admitted to the pediatric CICU during a one month period of time for patients aged 0 to less than or equal to 22 years of age, as per the World Health Organization definition of a pediatric patient.
Receives: Other: Decibel Monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To measure peak and mean sound levels in a cardiac ICU as well as sound dose and to compare this exposure to WHO recommendations

    Measured: 1 month

Secondary outcomes (3)
  1. To correlate sound levels and sound dose with bolus sedation administered to these patients

    Measured: 1 month

  2. To correlate sound levels and sound dose with delirium scores in these patients

    Measured: 1 month

  3. To correlate sound levels and sound dose with patient heart rate

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2021
  2. Study start1 Mar 2021
  3. Primary completion1 May 2021
  4. Study completion1 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04777695
Sponsor's protocol ID
Pro00013873
Status last verified
Sep 2021
First submitted
22 Feb 2021
Last updated
1 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Garcia Guerra G, Joffe AR, Sheppard C, Pugh J, Moez EK, Dinu IA, Jou H, Hartling L, Vohra S; SedationWithdrawal and Analgesia Team (SWAT); Canadian Critical Care Trials Group (CCCTG). Prospective cohort study on noise levels in a pediatric cardiac intensive care unit. J Crit Care. 2018 Apr;44:318-322. doi: 10.1016/j.jcrc.2017.12.008. Epub 2017 Dec 14.

    PubMed 29274594

Questions about this trial

What is this clinical trial studying?

An observational study of Noise Exposure and Sedative Withdrawal Delirium, run by Children's National Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To measure peak and mean sound levels in a cardiac ICU as well as sound dose and to compare this exposure to WHO recommendations (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04777695, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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